JP2013535301A - Ultrasonic probe head support / cover structure - Google Patents

Abstract

A probe cap for use with an ultrasonic probe including a head portion and an acoustic surface is provided.
In one embodiment, a probe cap includes a body formed with a cavity sized to removably receive a probe head portion therein. The probe cap body is further formed with a hole near the acoustic surface of the head portion. In this hole, a flexible spacer component is arranged. The spacer component may comprise a hydrogel and forms an acoustic path between the acoustic surface and the patient's tissue surface. The spacer component includes a skin contacting surface in which a recess is formed. This contact surface can be deformed against the tissue surface. Additional embodiments disclose various probe caps and associated needle guide configurations used to assist clinicians with ultrasound probes and inserting needles into patients. Yes.
[Selection] Figure 25D

Description

  This application is a continuation-in-part of US patent application Ser. No. 12 / 900,750, filed Oct. 8, 2010, entitled “Spacers for Use with Ultrasonic Probes”. This application claims the benefit of US Provisional Patent Application No. 61 / 372,044, filed Aug. 9, 2010, entitled “Support and Cover Structure for Ultrasonic Probe Heads”. The entire contents disclosed in these applications are hereby incorporated by reference into the present disclosure.

  Briefly summarized, embodiments of the present invention relate to a probe cap for use with an ultrasonic probe comprising a head portion and an acoustic surface. In one embodiment, the probe cap includes a body that defines a cavity sized to removably receive a head portion of the probe therein. The probe cap body is further formed with a hole in the vicinity of the acoustic surface of the head portion. A flexible spacer component is placed in the hole. The spacer component may be formed comprising a hydrogel and provides an acoustic path between the acoustic surface and the patient's tissue surface. The spacer component further includes a skin contacting surface that forms a recess. This skin contact surface can be deformed in contact with the skin. The skin contacting surface may further form one or more spacer elements adjacent to the recess to distribute the load of the probe that is pressed against the skin and prevent the patient's subcutaneous structure from being compressed.

  In another embodiment, an ultrasound imaging system for imaging a patient's subcutaneous structure is disclosed. The system includes a display, an ultrasound probe having an acoustic surface that emits an ultrasound signal, and first and second spacer elements. These spacer elements are positioned near both ends of the acoustic surface and are configured to form a gap between the acoustic surface and the patient's tissue surface. Thus configured, the spacer element prevents the patient's subcutaneous structure from being compressed.

  In addition, the embodiments described in more detail below include various probe caps and these probe caps for use in assisting clinicians to insert a needle into a patient using an ultrasound probe. The structure of the attached needle guide is disclosed.

  These and other features of embodiments of the present invention will become more apparent from the following description and appended claims, and will be understood by implementing the embodiments of the invention as described below. It will be.

  The present disclosure will be described in more detail with reference to specific embodiments of the invention illustrated in the accompanying drawings. It will be understood that these drawings depict only typical embodiments of the invention and therefore should not be considered as limiting the scope of the invention. Exemplary embodiments of the invention will now be described in more detail with reference to the accompanying drawings.

1 is a perspective side view of an ultrasound probe including a spacer element configured according to one embodiment. FIG. 1B is a schematic cross-sectional view of the ultrasound probe of FIGS. 1A and 1B used for imaging a patient's blood vessels. FIG. 1B is a side view of the ultrasound probe of FIGS. 1A and 1B wrapped with a sheath according to one embodiment. FIG. FIG. 4 is a side view of a portion of an ultrasound probe that includes a spacer element and illustrates a possible acoustic surface configuration according to one embodiment. 1 is a side view of a portion of an ultrasound probe including a spacer element according to one embodiment. FIG. FIG. 3 illustrates an ultrasonic spacer element configured in accordance with one embodiment. FIG. 3 illustrates an ultrasonic spacer element configured in accordance with one embodiment. FIG. 3 illustrates an ultrasonic spacer element configured in accordance with one embodiment. FIG. 3 shows a spacer element configured in accordance with one embodiment. 1 is a side view of an ultrasound probe including a spacer element configured in accordance with one embodiment. FIG. 1 is a side view of an ultrasound probe comprising a cap according to one embodiment having a spacer element and a sheath. FIG. FIG. 6 is a perspective view of a spacer component according to one embodiment. FIG. 13 illustrates a method of using the spacer component of FIG. 12 according to one embodiment. FIG. 6 is a side view of a spacer component according to one embodiment. FIG. 15 illustrates a method of using the spacer component of FIG. 14 according to one embodiment. It is a disassembled perspective view of the ultrasonic probe and probe cap by one Example. It is the figure which looked at the probe cap of FIG. 16 from various viewpoints. FIG. 2 is an exploded perspective view and a side cross-sectional view of an ultrasonic probe / probe cap and a spacer component, respectively. It is sectional drawing of the head part of the ultrasonic probe of FIG. It is sectional drawing of the probe cap of FIG. FIG. 17 is a cross-sectional view of the head portion of the ultrasonic probe of FIG. 16 received within the probe cap of FIG. 16. FIG. 17 is another cross-sectional view showing the head portion of the ultrasonic probe of FIG. 16 received within the probe cap of FIG. 16. It is a perspective view of the structure which integrated the ultrasonic probe and probe cap of FIG. 24A and 24B are front and side views of an ultrasound probe and an attached probe cap that includes a flexible spacer component, according to one embodiment, and FIG. 24C is the probe cap of FIGS. 24A and 24B. FIG. It is the figure which looked at the probe cap by one Example from various viewpoints. It is the exploded view which looked at the probe cap comprised according to one Example from the various viewpoints. 26B is a side view of the probe cap of FIGS. 26A and 26B in contact with the patient's skin above the subcutaneous blood vessel. FIG. It is the perspective view and sectional drawing of the probe cap by one Example. It is the figure which looked at the probe cap assembly by one Example from various viewpoints. It is the perspective view which looked at the probe cap by one Example from various viewpoints. FIG. 30B is a side cross-sectional view of the probe cap of FIGS. 30A and 30B attached to an ultrasonic probe. It is a perspective view of the probe cap by one Example. FIG. 3 is a partial side cross-sectional view of an ultrasound probe and probe cap, according to one embodiment. It is a perspective view of the needle guide by one Example. FIG. 35 is a side and perspective view of the needle guide of FIG. 34 attached to a probe cap, according to one embodiment.

  Reference will now be made to the accompanying drawings, in which like structures have like reference numerals. It will be understood that the accompanying drawings are schematic representations of exemplary embodiments of the invention, are not limiting, and are not necessarily drawn to scale.

  For clarity, the term “proximal” refers to a direction that is relatively close to the clinician using the devices described herein, whereas the term “distal” is from the clinician. A relatively distant direction. For example, the end of a catheter placed in the patient's body is considered the distal end of the catheter, while the end of the catheter remaining outside the body is the proximal end of the catheter. Further, as used herein, including the claims, the words “including”, “has” and “having” are intended to be “comprising”. It has the same meaning as the word.

  Embodiments of the present invention generally relate to various components for separating the acoustic surface of an ultrasound probe from a patient's tissue surface during an ultrasound procedure for imaging a patient's subcutaneous tissue. Such ultrasound procedures are used, for example, in connection with placement of a catheter within a patient's blood vessel. As described below, the component for spacing the acoustic surface, in one embodiment, prevents unwanted compression of subcutaneous blood vessels, particularly superficial blood vessels, thereby improving imaging of such blood vessels by the probe. . In addition, the embodiments described further below include various probe caps and associated needle guide configurations for use in assisting clinicians to insert needles into a patient using an ultrasound probe. It is disclosed.

  Referring first to FIGS. 1A and 1B, these figures illustrate an ultrasound image according to one embodiment including an ultrasound probe 12 and a console 20 with a display 30 for displaying an image generated by the probe. System 10 is shown. In this embodiment, the probe 12 is operably connected to the console 20 via the cable 31. However, in one embodiment, the probe may be connected wirelessly.

  The probe 12 includes a head 32 formed by a longitudinal length 32A and a width 32B. The main body of the probe forms a front surface 33A, a rear surface 33B, and a side surface 33C as a whole. It should be understood that the above probe description is not intended to limit the principles described herein. The probe head 32 includes an acoustic surface 34 that extends along at least a portion of the longitudinal length 32A of the probe head. Ultrasonic impulses are emitted from the acoustic surface 34 to penetrate and image the subcutaneous portion of the patient. The size, shape and configuration of both the probe and the acoustic surface may be different from those described herein, provided that they are within the principles of this disclosure. FIG. 1A shows only one example of an ultrasound imaging system, and other systems that include other components also benefit from the principles described herein.

  As shown in FIGS. 1A and 1B, according to one embodiment, a probe head 32 is disposed at each end of a longitudinal length 32A adjacent to the acoustic surface 34 of the probe, generally designated by reference numeral 40. Two spacer elements marked with Each spacer element 40 provides an acoustic surface 34 and a surface of the patient's skin 36 or other tissue when the probe 12 is placed on the patient's skin to obtain a subcutaneous image, as described in more detail below. It acts as an extended surface that forms a gap 48 therebetween.

  More particularly, each spacer element 40 of this embodiment forms a blade-like surface that includes a contact surface 42 for contacting the patient's tissue / skin 36. As described in detail below, the contact surface 42 may be formed in one of several configurations.

  Reference is now made to FIG. If the ultrasonic probe is not provided with a spacer, its acoustic surface directly contacts the patient's skin during imaging, thereby undesirably compressing the subcutaneous blood vessel located under the probe. Sufficient pressure is generated to do this. Furthermore, the close proximity of the probe's acoustic surface to the patient's skin causes the probe's focal point to be located below the blood vessel to be imaged, resulting in superficial blood vessels or It makes the image resolution of other objects non-optimal.

  In contrast to the above description, FIG. 2 shows the probe 12 with a spacer element 40 disposed at each longitudinal end of the probe head 32 adjacent to the acoustic surface 34. As such, the acoustic surface 34 is spaced from the patient's skin 36 during use of the probe, and only the contact surface 42 of the spacer element 40 is in contact with the patient's skin 36. Thus, a gap 48 is formed between the acoustic surface 34 and the patient's skin 36. In one embodiment, the gap 48 may be filled with an ultrasonic gel 84 or other sound transmissive material to improve imaging.

  Since the acoustic surface 34 of the ultrasound probe head 32 does not directly contact the patient's skin 36 during use of the probe, the acoustic surface 34 does not apply pressure to the skin, so that the probe 12 is below the probe 12. A certain blood vessel 50 is not compressed during its use. Instead, the downward force applied by the probe 12 is directed through the spacer element 40. In this way, the blood vessel 50 below the acoustic surface 34 leaves the patient intact and can be imaged accurately. In addition, a large distance is formed by the gap 48 between the acoustic surface 34 and the patient's skin 36, and the focal point of the probe 12 is moved to a relatively close location below the skin surface. This allows superficial blood vessels or other objects near the skin surface to be placed closer to the focal point of the probe, and imaging can be performed clearly.

  The gap 48 shown in FIGS. 1A-2 is bounded by the acoustic surface 34, skin 36 and spacer element 40 during use of the probe. Thus, the gap 48 maintains a state where the lower surfaces of the front surface 33A and the rear surface 33B of the probe 12 are opened. If desired, additional spacers may be used to further limit the gap 48.

  Reference is now made to FIG. 3 in describing one embodiment. In this embodiment, a sheath 52 is placed over the probe 12 to form a sterilized location around the probe. The sheath 52 is relatively tight between the sheath and the side 33C of the probe and the front 33A and back 33B so that the ultrasonic gel 84 is contained and confined in the gap 48 by the sheath and spacer element 40. So as to fit around the probe 12. Note that many different types and configurations of sheaths or barriers may be used.

  4A and 4B show an exemplary surface configuration of the acoustic surface 34. In FIG. 4A, the acoustic surface 34 is flat so that it is substantially parallel to the patient's skin 36 during use of the probe. In FIG. 4B, the acoustic surface 34 forms a concave shape with respect to the skin 36. This configuration assists in capturing a predetermined volume of ultrasonic gel within the gap 48. Of course, other acoustic surface configurations may be used.

  FIG. 5 shows an example of a possible configuration of the contact surface 42 of the spacer element 40. In this example, the contact surface forms a convex shape for engaging the patient's skin or other tissue surface. Note that this is in contrast to the relatively flat contact surface 42 shown, for example, in FIGS. 4A and 4B. Other spacer contact surface shapes may be used including linear shapes, rounded shapes, and angled shapes.

  FIG. 6 illustrates the height “H” of each spacer element 40 according to a particular need or application in order to create a predetermined separation distance between the acoustic surface 34 and the patient's skin 36 during use of the probe 12. Indicates that it can be determined. Note that in one embodiment, the spacer element is integrally formed with the probe housing. In another embodiment, the spacer element is removably attached to the probe. The spacer element may be formed including the same material as the material of the probe housing, or may be formed including a different material.

  Referring now to FIGS. 7 and 8, FIG. 7 illustrates that in one embodiment, the spacer element 40 may be configured to extend a distance “E” longitudinally beyond the side 33C of the probe 12. FIG. Show. In FIG. 8, each spacer element 40 is provided inward from the side surface 33 </ b> C of the probe 12 by a distance “I”.

  9A and 9B show yet another possible spacer element configuration according to one embodiment. In such a configuration, each spacer element 40 is provided at one end of an extension arm 48 extending from a corresponding one of the front surface 33A and the rear surface 33B of the probe 12. Such a configuration is useful, for example, in advancing the probe 12 along the patient's skin 36 in a direction parallel to the longitudinal length of the acoustic surface 34. Accordingly, these and other spacer configurations are considered to be within the spirit of the present disclosure.

  FIG. 10 shows a height adjustable spacer element 40 that can vary the set-off distance of the acoustic surface 34 from the skin 36. In the illustrated embodiment, a bracket 60 for slidingly receiving the spacer element 40 is provided on the side surface 33C of the probe 12. The bracket 60 is provided with a recess or hole 62. The spacer element 40 is provided with protrusions 64 corresponding to these depressions. These protrusions 64 are configured to be selectively received within the holes 62 so as to releasably lock the spacer element in place at a particular height. The plurality of protrusions 64 are distributed along the length of the spacer element 40 such that one of a number of spacer heights is selected. Similarly, an adjustable spacer element is provided on the opposite side of the probe 12. Of course, other adjustable spacer element configurations may be provided on the probe in addition to the configurations explicitly described herein.

  FIG. 11 is a detailed view of yet another embodiment. In this embodiment, a spacer element 40 is provided on a cap 70 that can be removably attached to the probe head 32. In this embodiment, the cap is snapped onto the probe head 32 by an interference fit, but other embodiments use other attachment methods, including, for example, providing a surface that interengages the probe and cap. May be. The sheath 72 is attached to the cap 70 so as to provide a sterilization barrier for the ultrasound probe 10. In one embodiment, cap 70 and sheath 72 are disposable.

  It should be understood that the number, size, height, shape, etc. of the spacer elements may differ from the embodiments explicitly described herein. For example, one, three or more spacers may be provided. Alternatively, the relative heights of the spacers may be different from each other so that the probe is inclined with respect to the skin. The probe may have one of many different shapes, configurations, etc. Thus, these and other variations are considered to be part of this disclosure.

  FIG. 12 shows details of a spacer component 78 configured to be attached to the probe head 32 according to one embodiment, as shown in FIG. 13A. The spacer component 78, in one embodiment, includes a body formed of a flexible material, such as a hydrogel, that substantially maintains its intended shape when there is no deformation force. The flexible material includes, in one example, Aquaflex (AQUAFLEX is a registered trademark) ultrasonic gel available from Parker Laboratories, Fairfield, NJ. The spacer component 78 is further formed with a spacer element 80 at each of its longitudinal ends, and a recess 82 is formed between these spacer elements. It will be appreciated that other suitable materials may be used for the flexible material of the spacer component. Such materials include materials such as soft silicone, rubber, and the like that are permeable to sound waves and sufficiently filled. In one embodiment, the flexible material is thermoformable, sterilizable, and has a shelf life of at least one year.

  As shown in FIGS. 13A, 13B, and 13C, the spacer component 78 is flexible so that it can be deformed to conform to the shape of the surface of the patient's skin 36 during use of the probe 12. For example, the probe 12 including the spacer component 78 can be placed on the patient's arm. When so positioned, the spacer 80 of the spacer component 78 conforms to the cross-sectional curvature of the arm surface and can be deformed as necessary to remain in contact with the arm skin 36. Figures 13B and 13C illustrate such a variation of the spacer component 78 for a relatively thick arm. Thus, the spacer component 78 provides an acoustic path between the acoustic surface and the skin surface without the need for a flowable ultrasonic gel. It will be appreciated that the spacer component may be used in connection with imaging other parts of the patient's body and may be formed in other shapes for contacting various shaped body parts. . Further, in one embodiment, an ultrasonic gel may be included between the spacer component and the skin, for example in the recess.

  FIG. 14 shows a spacer component 90 according to another embodiment. The spacer component 90 includes a flexible casing 92 that can be operatively attached to the probe head 32 as shown. The casing 92 includes an arm 92 </ b> A that houses a flexible insert 94. The insert 94 is a hydrogel or the like in one embodiment. As shown in FIGS. 15A and 15B, the spacer component 90 provides clearance and acoustics between the acoustic surface 34 and the surface of the skin 36 or other tissue surface without the need for a flowable ultrasonic gel. Positioned on the probe head 32 to provide both paths. As so configured, the insert 94 forms a contact surface 96 for contacting the surface of the skin 36 during use of the ultrasound probe. In one embodiment, the shape of the contact surface 96 may be changed by pushing the arm 92A of the casing 92 inward. For example, FIG. 15A shows that a relatively shallow recess 98 is formed in the contact surface 96 of the insert 94 when the arm 92A of the casing 92 is deflected outward. However, when the arm 92A is pushed inward as shown in FIG. 15B, the insert 94 is compressed by the arm, and the recess 98 of the contact surface 96 becomes relatively large. Such a configuration of the contact surface 96 is desirable to stabilize the position of the subcutaneous blood vessel without collapsing the subcutaneous blood vessel. The arm 92A can itself be biased to regain a given position when not being pushed by the user.

  FIG. 16 shows details of a probe cap 110 for use with the probe 12 according to one embodiment. The cap 110 is configured to receive a head 32 of the probe 12 therein and provide a spacer component 118 for providing a desired spacing between the acoustic surface 34 of the probe head 32 and the skin 36. .

  As shown in FIGS. 17A to 17D, the cap 110 forms a cavity 112 sized to receive the head 32 of the probe 12 therein. In order to removably and mechanically attach the cap to the probe 12, the cap 110 is provided with an engagement structure 114, but it will be understood that various configurations can be used to achieve the same function. The cap 110 is also a removable needle to assist the clinician in placing the needle through the skin 36 after detecting the position of the blood vessel by using the ultrasound system 10 (see FIG. 1A). A needle guide base 116 on which a guide can be placed is included.

  With continued reference to FIGS. 17A-17D, further reference is made to FIGS. 18A and 18B showing various details of the spacer component 118. The spacer component 118 is disposed in a hole 130 formed in the cap 110, best shown in FIGS. 17A and 17C. As shown, the spacer component 118 includes a skin contacting surface 126 that forms two spacer elements 120 and a recess 122 disposed between the spacer elements. The spacer component 118 is formed in one embodiment to include a flexible material such as a hydrogel, but it will be understood that it may be formed using other suitable materials. The spacer component 118 thus does not require the use of a flowable ultrasonic gel to be applied to the skin 36 to provide an acoustic path between the acoustic surface 134 and the patient's skin. Around the spacer component 118 is further formed a lip 128 to assist in retaining the spacer component 118 in the hole 130 of the cap 110, as can be seen in FIG. 18B. As shown in the figure, in this embodiment, the lip 128 is formed in a shape that is sandwiched between the cap 110 and the probe head 32, and therefore does not accidentally come off the cap.

  FIG. 19 shows that in this embodiment, the acoustic surface 134 of the probe head 32 forms a convex shape. Correspondingly, FIG. 20 shows that the probe contact surface 136 of the flexible spacer component 118 also forms a convex surface. FIG. 21 shows that when the probe head 32 is received in the cavity 112 of the cap 110, the probe contact surface 136 having the convex shape of the spacer component 118 is deformable with the acoustic surface 134 having the convex shape of the probe head 32. To ensure a secure contact between them and form a suitable acoustic path through the spacer component. Of course, other complementary shapes may be used for the acoustic surface and the probe contact surface of the spacer component.

  FIG. 22 shows another view of the engagement between the probe head 32 and the cap 110 according to this embodiment. The cap 110 is provided with a recess 138 that receives the alignment protrusion 140 of the probe head 32. This protrusion provides a landmark for directing the ultrasound image to the display 30 (see FIG. 1A) in the orientation of the probe 12 held by the clinician. FIG. 23 shows the cap 110 removably attached to the probe 12. The cap 110 includes a spacer component 118. In one embodiment, the cap provides a sterilization barrier for the probe head and is disposable.

  FIGS. 24A, 24B and 24C illustrate a probe cap 110 and a concave shaped flexible spacer component 118 and the ultrasound probe 12 according to one embodiment. As shown, a suitably shaped cover 148 for covering the spacer component 118 to prevent the spacer component 118 from becoming dirty and to prevent the spacer component 118 from drying prior to use. Is included. If the cover 148 is to be used on the probe cap, the clinician need only remove and discard the cover 148 attached to the probe cap 110 by friction or other suitable fit.

  As best seen in FIG. 24C, the cap 110 in this embodiment is a bracket 144 to which the needle guide can be removably attached so that the needle can be guided toward the desired blood vessel imaged by the ultrasound probe 12. including. Further details regarding one non-limiting example of a needle guide that can be attached to the bracket 144 can be found in, for example, US Provisional Patent Application entitled “Angle Selectable Needle Guide” filed December 22, 2010. 61 / 426,297. The entire contents disclosed in this application are hereby incorporated by reference into the present disclosure. It should be noted that the needle guide and bracket can be varied from the embodiments described herein.

  The following discussion discusses yet another structure for enhancing the usability of an ultrasound probe in connection with placing catheters and other medical devices within a patient's body. Indeed, these embodiments disclosed herein facilitate use when imaging a portion of a patient's body in preparation for placing the device in the patient's body. Examples of such placement methods include a clinician inserting a needle, PICC catheter, PIV catheter, midline catheter, etc. into the patient's body through a percutaneous insertion site.

  25A to 25D are detailed views of the probe cap 160 according to one embodiment. The probe cap 160 is formed with a cavity 162 for receiving the head 32 of the probe 12 therein, and an engagement structure 164 for allowing the cap to be removably engaged with the probe head 32. A jig 166 is provided on the side of the cap 160. The jig 166 is configured to removably receive the needle guide 192. In another embodiment, the needle guide and other needle guides disclosed herein may be non-removably attached to the cap. Although not shown here, a spacer component similar to that shown and described in connection with FIGS. 24A-24C is provided for the cap 160 to provide an acoustic path from the probe head 32 to the patient's skin. Note that it is located in the hole 130.

  As best seen in FIG. 25D, the needle guide 192 forms a channel 194 that can temporarily receive a portion of the cannula of the needle to be inserted into the patient. The channel may be sized to accept needle cannulas of various sizes / diameters, as shown in this figure, or configured to accept a pre-determined predetermined size needle. Note that it may be. An abutment surface 196 is formed at the distal end of the channel 194, and the needle is centered about the abutment surface 196 so as to continuously form various angles of attack with respect to the patient's skin during the needle insertion procedure. Can pivot. In this way, the needle guide 192 can be any one of various angles of attack toward the patient's skin while maintaining alignment between the needle and the subcutaneous blood vessel being imaged by the probe 12. You can guide at.

  The probe cap 160 and other caps discussed herein may be integrated with the head portion of the ultrasound probe in a variety of ways including friction fit, clip-pocket engagement, adhesive, hook-loop, etc. Can be configured. Further, the cap portion of the probe cap may be different from the configuration shown and described herein.

  The cap 160 further includes a stabilizing arm 200 that extends from the distal portion of the cap body. The stabilization arm 200 is configured to hold the probe with the cap vertically during the ultrasound imaging procedure and rest on the patient's skin when placed against the patient's skin and thus. The probe can be stabilized in the vertical position. Furthermore, the stabilization arm 200 can assist in securing the cap-equipped probe to the patient's skin, for example, by using a cord or elastic band that extends around and on the patient's arm. Thus, the ultrasonic probe is maintained in an upright position without being touched by the clinician during use, increasing the clinician's freedom during the imaging procedure. In one embodiment, the stabilization arm 200 is further formed with a hole 202. The clinician can push the patient's skin through this hole to locate and plug the subcutaneous blood vessel. In this embodiment, the area near the periphery of the hole 202 is formed in an inclined shape to assist the clinician placing his finger. 26A and 26B show various details of a probe cap 210 according to another embodiment. The probe cap 210 includes a cavity 212 formed by the cap body. The cavity 212 is configured to receive the head 32 of the ultrasound probe 12 in a snap fit or other suitable manner therein. The cap body is further provided with a jig 216 for receiving the needle guide.

  A flexible membrane 218 is provided for attachment to the cap body. A lip 218A is formed around the membrane 218. Specifically, the cap body is provided with a protrusion 219 around the hole 230 at the distal end of the cap body. The lip 218A of the membrane 218 is configured to be elastically attached to the protruding portion 219 so as to cover the ultrasonic transducer of the probe head 32 when the cap 210 is attached to the probe 12 so as to couple the membrane to the cap body. Has been. Thus, the membrane 218 forms an acoustic path between the transducer and the patient's skin. It should be noted that during ultrasound imaging, an ultrasonic gel may be applied to the patient's skin along with the cap 210, or it may not be necessary to use it. Furthermore, in one embodiment, the membrane 218 is made of silicone, but it should be noted that other suitable flexible materials may be used.

  More specifically, the protrusion 219 is formed with a concave recess 222 as best seen in FIGS. 26A and 27. Thereby, two standoffs (spacers), that is, spacers 220 are formed at both ends. Because the membrane 218 is flexible, it can be deformed to conform to the recess 222 of the protrusion 219 when the membrane is placed against the patient's skin during an ultrasound procedure. Thus, the membrane 218 allows the patient's skin to be imaged during ultrasound imaging without applying an undesired compressive force to the subcutaneous structure such as the superficial blood vessel 50 shown in FIG. 36 and the shape can be matched.

  28A and 28B show a probe cap 260 according to one embodiment. A cavity 262 and a jig 266 for receiving the needle guide are formed in the main body of the cap. An ultrasonically permeable membrane 268 is provided near the opening 280 at the distal end of the cap body to cover the transducer of the head of the ultrasonic probe inserted into the cap body. An ultrasonic transmission medium such as an ultrasonic gel 269 may be placed on the inner surface of the membrane 268 to ensure an acoustic connection between the transducer and the patient's skin. Similar to the caps of the other embodiments described herein, the probe cap 260 is configured as a sterile cap to provide sterility to the ultrasound probe or to isolate the ultrasound probe. Can. Spacers 270 may be provided on both sides of the membrane 268 to prevent superficial blood vessels from being compressed by the cap 260 when the cap 260 is placed against the skin. It should be noted that an ultrasonic gel may also be placed between the membrane 268 and the patient's skin to improve signal transmission if desired.

  29A-29D show details of a probe cap assembly 310 according to another embodiment. In this embodiment, the assembly includes a cap body formed with a cavity 312 for receiving the head 32 of the ultrasound probe 12 therein, as in the previous embodiment. Further, an engaging structure 314 is provided to fix the cap body to the probe 12 as in the above-described embodiment.

  The cap body can move between two parallel rails 350 of the bracket 340. Each rail 350 is provided with a plurality of slots 352 that align with corresponding slots in the opposing rail 350. Tabs 319 provided at both longitudinal ends of the cap body are configured to be selectively received in corresponding opposing slots 352 of the rail 350, as shown in FIGS. 29A-29D. In the illustrated embodiment, the cap body can be selectively repositioned along the bracket rail 350. This repositioning involves manually lifting the cap body to disengage the tabs 319 from the corresponding slots 352, repositioning the cap body as desired relative to the slots on the bracket rail, and then inserting the tabs into the selected slots. Is done by. It will be appreciated that in other embodiments, other methods for moving the cap body relative to the bracket are possible. Such methods include sliding movement, gear drive movement, and the like.

  As best seen in FIGS. 29B-29D, the bracket is provided with a needle guide 342 for guiding the needle into the patient's body when the probe cap assembly 310 is placed on the patient's skin. Further, the bracket 340 is provided with an observation hole 346 so that a clinician who inserts the needle can observe the blood flashback when the needle enters the subcutaneous blood vessel.

  It should be noted that the needle guide 342 of the present embodiment is disposed at a predetermined angle fixed with respect to the bracket 340, and the cap body can be moved relative to the needle guide along the bracket. Thus, with this configuration, the subcutaneous tissue can be imaged at various discrete distances from the needle guide by means of an ultrasonic probe disposed within the cap body. In addition, this configuration allows the needle inserted through the needle guide 342 to be inserted into an ultrasound imaged blood vessel or other object at any one of a plurality of subcutaneous depths. You can enter without having to adjust the angle of attack.

  More specifically, the probe 12 can be ultrasonically imaged in the patient's body under the condition that the probe 12 is disposed in the cap body of the probe cap assembly 310, and the depth of the blood vessel below the skin surface can be measured. I can confirm. A number is attached to one or more slots 352 indicating the depth under which the needle inserted into the patient through the needle guide 342 captures the subcutaneous blood vessel. Thus, the bracket 340 can be adjusted until the tab 319 of the bracket 340 is positioned in the slot 352 of both rails 350, corresponding to the depth of the imaged blood vessel. As the needle is inserted through the needle guide 342 into the patient's skin, the needle can be advanced as desired until the needle has captured and entered the imaged blood vessel of the predetermined depth. As described above, the probe cap assembly 310 can assist the access using the fixed angle needle guide of the needle to the blood vessel imaged by ultrasonic waves regardless of the depth of the blood vessel, and thus, in this embodiment, the angle can be adjusted. It will be appreciated that a simple needle guide is not required. The depth measurement of the bracket may be performed in a manner other than that shown, but in one embodiment, the depth accessible using the probe cap assembly 310 is from about 0.3 cm to about 1.5 cm. Please note that.

  30A and 30B show a probe cap 360 according to another example. In this embodiment, the cap body is formed with a cavity 362 for receiving the head 32 of the ultrasonic probe 12 and an engagement structure 364 for fixing the cap body to the probe 12. A stabilizing arm 365 extends from the cap body. The stabilizing arm can secure the cap 360 (and the probe 12 received therein) to the patient, for example by a band wrapped around the stabilizing arm and the patient's arm.

  As shown, the probe cap 360 further includes a deflector portion 390 for deflecting both the ultrasound signal emitted from the transducer of the ultrasound probe 12 and the ultrasound signal traveling to the transducer. The deflector portion 390 is formed as part of the probe cap 360 and forms a channel 392 and an opening 396 through which ultrasound signals can pass. The deflector portion 390 further includes a deflection surface 394 disposed in the channel 392. In this embodiment, the deflection surface 394 is disposed at an angle of about 45 ° with respect to the transducer surface of the probe head 32 and deflects the ultrasonic signal emitted from the transducer at an angle of about 90 °. However, the deflection surface may be positioned at other angles in other embodiments to form various signal deflection angles relative to the probe transducer.

  FIG. 31 shows that the signal emitted from the transducer of the probe head 32 travels through the channel 392 and is deflected by the deflecting surface 394 and directed downwardly towards the patient's body 36. A probe cap 360 is shown positioned against it. The ultrasound signal reflected by the imaged subject in the body and entering channel 392 is similarly deflected by deflection surface 394 and travels toward probe head 32 for receipt by the transducer. The deflection surface 394 may be formed of any suitable material having a suitable density so as to reflect ultrasound signals traveling through the channel 392. In one embodiment, the deflection surface is formed including a plastic material. Further, in one embodiment, channel 392 may be at least partially filled with an ultrasonically transmissive medium such as an ultrasonic gel. In another embodiment, a hydrogel-based spacer component may be disposed in the channel 392, as in the previous embodiment. In yet another embodiment, the deflector portion may be integrated with the probe head itself without a probe cap. By using the deflection probe cap 360, the probe 12 can be positioned parallel to the patient's skin 36, thus eliminating the need for the clinician to hold the probe upright during use.

  FIG. 32 shows that an example deflection probe cap 360 can be included as part of an assembly similar to the assembly shown in FIGS. 29A-29D. The cap body can be selectively moved between the two rails 410 of the bracket 400. Each rail 410 receives a tab 369 provided on the cap body to position the probe cap at any one of a plurality of possible distances from the needle guide 402 provided on the bracket 400. A plurality of corresponding slots 412 are provided. Similar to the above-described embodiment, an observation hole 406 is provided near the needle guide 402. As described in detail above in connection with FIGS. 29A to 29D, the assembly shown in FIG. 32 allows blood vessels of various subcutaneous depths to be imaged with ultrasound, and blood vessels of the desired depths taken. By moving the bracket 400 relative to the probe cap 360 so that the needle captures the needle, a needle disposed in the fixed angle needle guide 402 can access blood vessels of various subcutaneous depths.

  33A and 33B illustrate a deflection probe cap 360 according to one embodiment. In this embodiment, the deflector portion 390 is hinged to the remaining portion of the cap body via a hinge component 420. The hinge component 420 may be, for example, a mechanical hinge or an integral hinge. As such, the deflector portion may be selectively positioned to deflect the ultrasonic signal along a deflection signal path 424A (see FIG. 33A) or the ultrasonic signal may be undeflected. It may be rotated out of the ultrasound signal path (see FIG. 33B) so that it can move along the signal path 424B. A latch 426 or other suitable means may be included to selectively secure the deflector portion 390 in place. Note that in one embodiment, the deflection probe cap may be adjustable to deflect the ultrasound signal at various angles.

  FIG. 34 illustrates a needle according to one embodiment that can be used with one or more of the probe caps described herein, such as the probe cap 460 shown in FIG. 35B, ie, can be directly attached to an ultrasound probe. A guide 450 is shown. As shown, the needle guide 450 includes a curved V-shaped open channel 454. The needle is placed in the center of the channel. As a result, during insertion of the needle, the clinician can continuously adjust the angle of attack θ of the needle at the insertion site as shown in FIG. 35A. Note that the shape of the channel may differ from the shape shown and described.

  The embodiments of the present invention may be implemented in other specific forms without departing from the spirit of the present disclosure. The above embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of these embodiments is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

DESCRIPTION OF SYMBOLS 10 ... Ultrasonic imaging system 12 ... Ultrasonic probe 20 ... Console 30 ... Display 31 ... Cable 32 ... Probe head 33A ... Front surface 33B ... Rear surface 33C ... Side surface 34 ... Acoustic surface 36 ... Skin 40 ... Spacer element 42 ... Contact surface 48 ... Crevice 50 ... Superficial blood vessel 52 ... Sheath 60 ... Bracket 62 ... Hole 64 ... Projection 70 ... Cap 72 ... Sheath 78 ... Spacer component 80 ... Spacer element 82 ... Recess 84 ... Ultrasonic gel 90 ... Spacer component 92 ... Flexible casing 92A ... arm 94 ... insert 96 ... contact surface 98 ... recess 110 ... probe cap 112 ... cavity 114 ... engaging structure 116 ... needle guide base 118 ... spacer component 120 ... spacer element 122 ... recess 126 ... skin contact surface 128 ... lip 130 ... Hole 134 ... Acoustic surface 136 ... Probe contact surface 138 ... Recess 140 ... Orientation protrusion 144 ... Bracket 148 ... Cover 160 ... Probe cap 162 ... Cavity 164 ... Engagement structure 166 ... Jig 192 ... Needle guide 194 ... Channel 196 ... Contact surface 200 ... Stabilization arm 202 ... Hole 210 ... Probe cap 212 ... Cavity 216 ... Jig 218 ... Membrane 218A ... Lip 219 ... Projection 220 ... Spacer 222 ... Recess 230 ... Hole 260 ... Probe cap 262 ... Cavity 266 ... Jig 268 ... Membrane 269 ... Ultrasonic gel 270 ... Spacer 280 ... Opening 310 ... Probe cap assembly 312 ... Cavity 314 ... Engagement structure 319 ... Tab 340 ... Bracket 342 ... Needle guide 34 ... Observation hole 350 ... Bracket rail 352 ... Slot 360 ... Probe cap 362 ... Cavity 364 ... Engagement structure 365 ... Stabilization arm 369 ... Tab 390 ... Deflector part 392 ... Channel 394 ... Deflection surface 396 ... Opening 400 ... Bracket 402 ... Needle guide 406 ... Observation hole 410 ... Rail 412 ... Slot 420 ... Hinge component 424A ... Deflection signal path 424B ... Non-deflection signal path 426 ... Latch 450 ... Needle guide 454 ... Open channel 460 ... Probe cap

Claims (23)

A cap for use with an ultrasonic probe,
A body formed with a cavity for removably receiving the head portion of the probe therein;
A stabilizing arm formed extending from the cap body to stabilize the cap against the patient's skin surface;
A cap comprising a needle guide included in the cap. The cap according to claim 1,
The stabilization arm is further formed with a hole that allows a clinician to contact the patient's skin near the needle insertion area,
A peripheral region in the vicinity of the hole is formed in an inclined shape. The cap according to claim 1,
Furthermore, an engagement structure for fixing the cap to the ultrasonic probe is provided,
A corresponding engagement structure is provided on the head portion of the ultrasonic probe head. The cap according to claim 1,
The needle guide can be removably attached to a jig provided on the cap body. The cap according to claim 1,
The needle guide includes a channel capable of movably receiving a portion of the needle,
The channel comprises an abutment surface;
The needle is pivotable within the channel against the abutment surface so as to selectively change the angle of attack of the needle relative to the skin of the patient. The cap according to claim 1,
A band that uses a band or strap to secure the stabilization arm to the patient so that the ultrasound probe rests against and supports the patient's skin. A cap for use with an ultrasonic probe,
A body formed with a cavity for removably receiving the head portion of the probe therein;
An opening formed at the distal end of the cap body, wherein a portion of the periphery of the opening is formed in a concave shape to form first and second spacer components When,
A membrane formed in a shape that covers the opening, and when the membrane is placed against a patient's skin, the membrane is flexible so that the shape can match the periphery of the concave opening. A cap with a membrane. The cap according to claim 7,
The first and second spacer components cause the skin to be compressed by the concave shaped portion around the opening when the distal end of the cap is placed against the skin of the patient. Cap that helps to prevent it from happening. The cap according to claim 7,
The membrane includes a lip attached to the periphery of the opening,
The cap includes a jig to which the needle guide can be removably attached,
The membrane is formed of a silicone cap. A cap assembly for use with an ultrasonic probe comprising:
A cap body formed with a cavity for removably receiving the head portion of the ultrasonic probe;
A bracket for movably supporting the cap body, the bracket having a needle guide;
The cap body is movable with respect to the bracket so that a distance between the needle guide and the cap body can be selectively changed. A cap assembly according to claim 10, comprising:
The needle guide forms a fixed angle of attack with respect to the needle disposed in the needle guide;
By selectively changing the distance between the needle guide and the cap body, the subcutaneous path of the needle can capture a desired subcutaneous object imaged by the ultrasound probe. A cap assembly according to claim 11, comprising:
The bracket includes a boundary display indicating a depth at which the needle captures a photographed subcutaneous object. Cap assembly. A cap assembly according to claim 10, comprising:
The bracket includes first and second rails,
The cap body is movably disposed between the first and second rails;
The first and second rails have a plurality of aligned slots in which a plurality of tabs disposed in the cap body are removably received to position the cap body at a predetermined distance from the needle guide. Cap assembly. A cap assembly according to claim 10, comprising:
The cap assembly is placed against a user's skin so that an ultrasonic signal generated by the ultrasonic probe is directed to the patient. A cap assembly according to claim 10, comprising:
The bracket further includes an observation hole in the vicinity of the needle guide for observing a flashback of blood from the needle. A cap for use with an ultrasonic probe,
A body formed with a cavity for removably receiving the head portion of the probe therein;
And a deflector portion for deflecting the ultrasonic signal emitted from the probe from the first direction to the second direction at a predetermined deflection angle so as to exit the opening of the probe cap. The cap according to claim 16, wherein
The opening is placed against the patient's skin so that the ultrasound probe is substantially parallel to the surface of the skin;
The cap further comprises:
A needle guide disposed in the deflector portion;
A stabilizing arm extending from the cap body. The cap according to claim 16, wherein
The cap is movably attached to a bracket having first and second rails;
The bracket includes a needle guide cap. The cap according to claim 16, wherein
The deflector portion comprises a deflection surface wherein the deflection angle is substantially about 90 °. The cap according to claim 16, wherein
The deflector portion is hinged to the cap body so as to be selectively removed from the ultrasound signal path. The cap according to claim 16, wherein
The deflector part is removable from the cap body. A needle guide,
With curved, open channels,
A needle guide capable of continuously adjusting an angle of attack of a needle disposed in the channel with respect to a skin surface of a patient by the channel. The needle guide according to claim 22,
The channel is a needle guide formed in a V shape so that the needle is positioned at the center of the channel.

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